Site Name: Marburg - Office, Dresden - Office
Posted Date: Feb 7 2025
We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2023. We continue to modernize, so we can launch even more new products at speed whilst continuing to deliver across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.
Supplier Quality Audit Lead (m/f/d)
TRAVEL: Please Note that there is a high proportion of travel involved with this role (throughout Europe). It is anticipated that this will represent circa 30% to 50% of the role.
We now have an exciting opportunity available to be part of the Central Supplier Quality Audit and Compliance (SQ A&C) function supporting the Pharma Supply Chain. The SQ A&C Pharma team supports the wider GSK manufacturing network globally by promoting quality and compliance throughout the product life-cycle. This is accomplished through quality assurance activities supporting the GSK supply chain, specifically GMP assessment of quality critical materials and services utilized throughout the GSK manufacturing network.
The Supplier Quality Auditor reports directly to the Supplier Quality Audit Senior Manager. The purpose of the role is to significantly contribute to the assurance that material and service suppliers to GSK’s manufacturing and supply-chain sites are in adequate compliance with GSK requirements and all applicable standards for relevant Regulatory Authorities.
Day-to-day, the successful candidate will be generally focused on planning, executing and documenting GMP and Quality Systems compliance audits/assessments for several assigned suppliers in region and managing associated supplier action plans arising from those audits/assessments to close identified gaps. In delivery of the above, the successful candidate will maintain audit and user site-data in the appropriate GSK supplier management systems. You will also have the opportunity to provide expertise and support for supplier change controls (as required/applicable).
Key Responsibilities
* Performing GMP/Quality System assessments/audits of assigned suppliers; making risk-based recommendation on supplier GMP approval status (including proposals for continued use of suppliers with marginal compliance) and documenting assessments/audits in relevant systems
* Agreeing appropriate corrective and preventive action (CAPA) plans with suppliers and follow-up on the completion of CAPAs (within agreed timelines)
* Effective communication of assessment outcomes to internal and external stakeholders
* Ensuring audit-related documentation is effectively communicated and that CAPA-related documents are reviewed and responded to within targeted timelines
* Maintenance of “auditee” (supplier) profiles in data systems, ensuring that supplier data associated with the supplier assessment and user sites are kept up to date (based on currently available information)
* Supporting change controls from assigned suppliers (as needed) as per current procedures
* Collating identified risks and escalating high risk issues/situations to ensure management and stakeholders understand technical, regulatory and quality risks (and that appropriate mitigating actions are identified)
* Provide support to GSK sites undergoing regulatory/customer inspections (as assigned)
As this role is multi-faceted and includes liaising with a wide variety of on-site and third-party production and operations teams, you will be a confident, self-motivated and self-managing individual who has strong auditing experience (obtained whilst working in quality and/or manufacturing at a complex manufacturing site) across a wide variety of commodities and proven ability to work remotely as part of a matrix organization. You will be passionate about quality-control and auditing, with strong people skills and a continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organize and prioritize workload are considered essential skills as well as ability to speak and write technical documents in English. You will be curious and able to assimilate multiple information sources into rational conclusions. Experience in / knowledge of API manufacturing, sterile manufacturing or biopharmaceutical manufacturing a definite plus.
Qualifications & Skills
* Degree in Life Science or other relevant discipline
* Relevant experience (ideally gained from the working in a highly regulated environment like Pharmaceutical Manufacturing)
* Knowledge of current GMP requirements within major pharmaceutical markets
* Knowledge and application of the principles of the Quality Management Systems (QMS)
* Comfortable with verbal and written English
Preferred Qualifications & Skills
* Knowledge of / experience in API, sterile, parenteral, and/or biopharmaceutical manufacturing processes / environments
* Auditor certification from relevant external organization and/or GSK auditor certification.
LOCATION: The successful candidate may be based at any of the GSK Pharma/Vaccine manufacturing sites in Europe/UK. Location at the following GSK sites is preferred: Marburg (Germany) and Dresden (Germany)
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GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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